Did Janssen And Johnson & Johnson Promote Invokana For Off-Label Use?

The FDA approved the drug Invokana for use in those with Type 2 diabetes
in March, 2013. While this was the only approved use for Invokana, it
appears the drug may have been promoted for off-label use, specifically
for weight loss. One Invokana advertisement claims a “secondary
endpoint of greater reductions in body weight.” For a variety of
reasons, this off-label promotion may well become a factor in the liability
analysis of future Invokana cases. In order to understand the issues with
promoting Invokana for weight loss, it is necessary to understand just
how the drug works.

How SGLT-2 Inhibitors Work in the Body

Most diabetics in the United States are Type 2 diabetics which means the
body does not produce enough insulin to properly metabolize the sugars
being put into the body. This can result in weight issues as well as a
condition known as insulin resistance. Those with Type 1 diabetes (also
known as juvenile diabetes) can experience excessive thirst and frequent
urination, and may shed large amounts of weight when they develop a condition
known as ketoacidosis. This condition occurs when the body is unable to
metabolize sugar, making it a toxin in the bloodstream. Because the body
cannot metabolize the sugar, it attempts to excrete as much as possible,
depleting the volume of the body as water is pulled from the cells. In
effect, the body cannibalizes itself.

SGLT-2 inhibitors, such as Invokana, work in somewhat the same way; instead
of metabolizing blood sugars, like insulin or older diabetic drugs do,
the SGLT-2 inhibitor blocks reabsorption of the glucose after it passes
through the kidneys. The SGLT-2s use the kidneys in what many consider
an unnatural manner by helping the body excrete sugar through urination.
In other words, Invokana allows high amounts of blood sugar to enter the
kidneys, blocking the reabsorption process so the blood sugar is not being
recycled, after it has gone through the kidneys. This process can lead
to diabetic ketoacidosis, meaning the patient may, in fact, lose weight,
but through an unnatural and potentially dangerous process.

Public Citizen Condemns Off-Label Marketing of SGLT-2 Inhibitor Drugs

A letter written by consumer advocacy group, Public Citizen, urged the
FDA to fine Janssen Pharmaceuticals as well as AstraZeneca and other drug
manufacturers for off-label marketing of their Type 2 diabetes drugs.
The letter accuses the FDA of failing dismally to oversee such matters.
Five direct-to-consumer advertisements for five different drugs were targeted
in the letter, including: Janssen’s Invokana, Novo Nordisk’s
Victoza, Boehringer Ingelheim’s Jardiance and AstraZeneca’s
Farxiga and Bydureon.

While none of these drugs have been approved to help patients lose weight,
the advertisements convey to consumers and doctors that the drugs have
been deemed safe and effective for weight loss. Because all of the five
drugs listed have been associated with serious potential side effects,
Public Citizen believes the advertisements promoting weight loss skewer
the risk-benefit calculations made by physicians and consumers. In fact,
while not approved for weight loss efforts, all five drugs have FDA-approved
labels in which weight loss benefits are indicated in the fine print.
In response, Janssen stated its claims regarding weight loss and lower
blood pressure had the FDA’s blessing. The FDA has not confirmed
or denied Janssen’s statement.

Other Dangers Associated with Invokana

In addition to potentially causing dangerous ketoacidosis, Invokana has
been associated with heart attack, stroke and kidney failure as well as
increasing both LDL and HDL cholesterol levels and causing frequent urinary
tract infections. Kidney failure is a serious complication linked to Invokana
use. Since kidney damage is already associated with diabetes, adding a
drug which can cause further kidney damage may not be a wise choice. Kidney
damage and kidney failure can result from ketoacidosis, therefore if Invokana
triggers ketoacidosis, kidney damage or kidney failure may be a byproduct.

Did Johnson & Johnson and Janssen Exhibit a Failure to Warn?

Invokana works by essentially blocking normal kidney function, therefore
some experts have suggested the link between Invokana and renal failure
should have been known before the drug was marketed. This may mean that
future lawsuits will apply the failure to warn laws on behalf of plaintiffs
harmed by Invokana or other SGLT-2 inhibitor drugs.

Cleveland Personal Injury Attorneys

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